
group. Correction of treatment was carried out in accordance with
these data.
Results: a study of the overall survival of patients with CLL receiving
ibrutinib, depending on cardiac monitoring, was carried out, starting
from the first visit. The age of pts in the active cardiac monitoring
group (n =81) and in the rest of pts (n =136) did not differ and
amounted to 66.0 (60.0‐70.0) years and 66.0 (59.0‐74.0) years
respectively. The number of men and women in the groups was
comparable. In the active cardiac monitoring group, there were
significantly more pts with AH ‐86.5% and with AF ‐42.7%
compared to 50.4% with AH and 15.9% with AF in the remaining pts
(p <0.0001 in both cases) and a comparable number of pts with
coronary artery disease. According to screening HM, there were
more pts with short episodes of AF in the active cardiac monitoring
group ‐31.4% versus 8.0% in the rest of the pts (p <0.0001).
Accordingly, the number of pts receiving cardiac treatment in the
active cardiac monitoring group was 87.6%, the rest was 53.6%
(p <0.0001). ECHO parameters did not differ in the groups. In-
dicators that significantly affect survival in the general group
(Charlson index, scores of the G8 questionnaire) did not have signif-
icant differences in the active cardiac monitoring group and in other
pts with CLL. The groups also did not differ in hematological status
and the number of cases of second tumors. Despite a significantly
more pronounced cardiac comorbidity, CLL pts under active cardiac
monitoring, including continuous remote monitoring, demonstrated
better survival compared to other patients (p <0.0001).
Conclusions: carrying out active cardiac monitoring, including con-
stant remote observation, allows achieving higher overall survival
rates for CLL pts, despite the more severe cardiac status compared to
other patients under the periodic supervision of a cardiologist.
Keywords: Cancer Health Disparities
No conflicts of interests pertinent to the abstract.
INDOLENT LYMPHOMAS
310 |INDUCTION R
2
FOLLOWED BY MAINTENANCE IN
PATIENTS WITH RELAPSED/REFRACTORY TRANSFORMED
FOLLICULAR LYMPHOMA: INTERIM ANALYSIS FROM THE
PHASE 3B MAGNIFY STUDY
F. Lansigan
1
, V. Parameswaran
2
, A. Yacoub
3
, C. M. Reynolds
4
,
S. H. Shao
5
, S. G. Moore
6
, M. Coleman
7
, D. J. Andorsky
8
, G. S.
Nowakowski
9
, M. J. Rummel
10
, J. Li
11
, J. R. Ahn
12
, M. Gharibo
12
,
J. P. Sharman
13
1
Dartmouth‐Hitchcock Medical Center, Division of Hematology and
Oncology, Lebanon, New Hampshire, USA,
2
Avera Research Institute,
Hematology, Transplantation, and Oncology, Sioux Falls, South
Dakota, USA,
3
University of Kansas Cancer Center, Department of
Hematology‐Oncology, Westwood, Kansas, USA,
4
IHA Hematology
Oncology Consultants, Ann Arbor, Ypsilant, Michigan, USA,
5
Compass
Oncology, Rose Quarter Cancer Center, Portland, Oregon, USA,
6
UNC REX
Cancer Center, REX Hematology Oncology Associates, Raleigh, North
Carolina, USA,
7
Clinical Research Alliance Inc, Weill Cornell Medicine,
New York, New York, USA,
8
Rocky Mountain Cancer Centers, US
Oncology Research, Boulder, Colorado, USA,
9
Mayo Clinic, Division of
Hematology, Rochester, Minnesota, USA,
10
Justus‐Liebig Universität,
Med. Clinic IV, Hematology, Giessen, Germany,
11
Bristol Myers Squibb,
Global Biometrics and Data Sciences, Princeton, New Jersey, USA,
12
Bristol Myers Squibb, US Medical Affairs Hematology, Princeton, New
Jersey, USA,
13
Willamette Valley Cancer Institute and Research Center,
US Oncology Research, Eugene, Oregon, USA
Background: The lenalidomide +rituximab (R
2
) combination has
shown complementary clinical activity and is tolerable in both
untreated and relapsed or refractory (R/R) patients with indolent
non‐Hodgkin lymphoma (iNHL). Few patients with iNHL, ∼2%
per year (Link et al. J Clin Oncol. 2013), experience transformation
to aggressive lymphoma, ie, transformed follicular lymphoma (tFL).
Methods: MAGNIFY is a multicenter, phase 3b trial (NCT01996865)
in patients with R/R FL grades 1—3b, tFL, marginal zone lymphoma,
and mantle cell lymphoma. Lenalidomide 20 mg on d 1—21 of a 28‐d
cycle +rituximab 375 mg/m
2
/wk cycle 1 and then every 8 wk
starting with cycle 3 (R
2
) is given for 12 cycles followed by
1:1 randomization in patients with stable disease, partial response, or
complete response/complete response unconfirmed (CR/CRu) to R
2
vs rituximab maintenance for 18 mo. The primary end point is pro-
gression‐free survival (PFS) by 1999 International Working Group
(IWG) criteria. Secondary end points include safety, CR rate, duration
of response, duration of CR (DOCR), time‐to‐response, time‐to‐next
antilymphoma therapy, and overall survival. This analysis evaluates
the interim primary endpoint of overall response rate (ORR) by 1999
IWG criteria and safety of R
2
induction in patients with tFL in the
induction intention‐to‐treat population.
Results: As of August 28, 2020, 14 patients with tFL were enrolled
(median age, 70.5 y [range, 42—83]); 93% had stage III/IV disease, and
64% had bulky disease (>7 cm or >3 cm �3 lymph nodes). All patients
received prior rituximab‐containing therapy. Median number of prior
antilymphoma treatments was 2 (range, 1—7). Seven patients (50%)
had disease progression from FL ≤24 mo after any prior treatment.
Median time from initial FL to tFL diagnosis was 29.2 mo (range, 0—
212.1). Median follow‐up was 37.1 mo for patients still alive; 8 pa-
tients (57%) have died, 7 from PD and 1 from adverse event (AE; res-
piratory arrest). Median duration of R
2
treatment during induction was
7.38 mo (range, 1.5—11.3). ORR was 50% (n =7), with 3 patients (21%)
having a CR/CRu. Median DOCR was not reached (95% CI, 2.8—NR),
and median PFS was 7.5 mo (95% CI, 2.6—32.5). The most common
treatment emergent AEs (TEAE) of any grade were (n, %) diarrhea (7,
50%), nausea (7, 50%), neutropenia (7, 50%), constipation (6, 43%),
fatigue (6, 43%), cough (5, 36%), decreased appetite (5, 36%), and hy-
pokalemia (5, 36%). Grade 3/4 TEAEs occurring in >1 patient included
neutropenia (6, 43%), pneumonia (3, 21%), hypokalemia (3, 21%),
leukopenia (2, 14%), and hypertension (2, 14%). Nine patients (64%)
discontinued induction lenalidomide (7 for PD and 2 withdrawals by
patient), and 5 (36%) entered maintenance treatment.
404
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SUPPLEMENT ABSTRACTS